This webinar will explain the regulatory path of an in vitro diagnostic (IVD) and Laboratory Developed Test (LDT). It will discuss the CLIA regulations for Laboratory Developed Tests (LDTs), including companion diagnostics (CDx) and how these differ from the FDA’s authority.
When it comes to CLIA-regulated clinical laboratories, there is always a big deal of confusion on the role of each regulatory authority in FDA-approved test/device and Laboratory Developed Test (LDT) (home-brew assays). The companion diagnostic (CDx) approach, an in vitro diagnostic (IVD) device that provides information that is essential for the safe and effective use of a corresponding therapeutic product, adds another layer of ambiguity in relation to its development, analytical validation, clinical qualification, approval and post-approval application.
This webinar will explain the regulatory path of a universal IVD device and LDT. It will discuss laboratory requirements to perform a diagnostic test on human samples.
Why Should You Attend:
The Clinical Laboratory Improvement Amendments (CLIA) program regulates laboratories that perform testing on patient specimens in order to ensure accurate and reliable test results. The FDA regulates manufacturers and devices to ensure that devices, including those intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, are reasonably safe and effective.When it comes to CLIA-regulated clinical laboratories, there is always a big deal of confusion on the role of each regulatory authority in FDA-approved test/device and Laboratory Developed Test (LDT) (home-brew assays). The companion diagnostic (CDx) approach, an in vitro diagnostic (IVD) device that provides information that is essential for the safe and effective use of a corresponding therapeutic product, adds another layer of ambiguity in relation to its development, analytical validation, clinical qualification, approval and post-approval application.
This webinar will explain the regulatory path of a universal IVD device and LDT. It will discuss laboratory requirements to perform a diagnostic test on human samples.
Areas Covered in the Webinar:
- Classes of tests used in clinical laboratory
- Regulatory paths for approval of a universal IVD device and LDT (standalone or as a CDx)
- Laboratory requirements to perform a diagnostic test on human samples
- Analytical validation or verification of FDA-approved IVD kit or LDT
- CLIA vs FDA authority
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:- Pharmaceutical company, CRO, IVD manufacturer, or reference lab building capabilities in CDx
- Pharmaceutical company-owned, CRO, reference, or hospital-based clinical laboratory providing tests for clinical trials
- Reference or hospital-based clinical laboratory providing tests as standard of care
- Startups IVD manufacturer seeking FDA approval for an IVD
Course Provider
Abdel Halim,
